510(k) K030961
- Device
- MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
- Applicant
- MICROLIFE CORP.
- 510(k) number
- K030961
- Product code
- LHD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-12
- Date received
- 2003-03-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Fertility Diagnostic, Proceptive
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Obstetrics/Gynecology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 8020605
- 3009238284
- 3012316249
- 3012228195
- 3020773178
- 3012725363
- 3016867013
- 3009307663
- 3030648160
- 9680225
- 3003993690
- 3013587414
- 3016099071
- 3008517993
- 3013501873
- 3033531398
- 3016866092
- 3001585609
- 3017415521
- 3006799946
- 2110898
- 2434008
- 3011197658
- 3015599655
- 3014848805
- 3005321947
- 3020161798
- 3014343954
Source Documents#
Other 510(k) Records For Product Code LHD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200163 | Ava Fertility Tracker | Ava AG | 2021-01-19 |
| K122337 | OVUSENSE | Fertility Focus, Ltd. | 2013-08-06 |
| K102499 | DUOFERTILITY | Cambridge Temperature Concepts , Ltd. | 2011-12-20 |
| K050094 | LADY COMP USA | Lady Comp USA | 2006-04-20 |
| K021978 | PETIT SOPHIA | Nishitomo Co., Inc. | 2003-04-08 |
| K002726 | TCOYF FERTILITY SOFTWARE VERSION 1.0 | Ovusoft, LLC | 2001-04-06 |
| K952756 | MEDI-AID BASAL THERMOMETER | Polymedica Industries, Inc. | 1995-09-25 |
| K945427 | B-D DIGITAL THERMOMETER | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-06-15 |
| K904211 | BIOSELF 2000 FERTILITY INDICATOR | Bioself, Inc. | 1992-10-14 |
| K901512 | L SOPHIA | Nishitomo Co., Inc. | 1990-07-20 |
| K880618 | FERTILITY FORECASTER COMPUTER PROGRAM | Fertile Time, Ltd. | 1988-06-24 |
| K870999 | GENDER CHOICE INFORMATION KIT, FEMALE AND MALE | Procare C/O Wiley, Rein & Fielding | 1987-07-14 |
| K870528 | OVU-TRAC OVULATION TIMING KIT | Ob/Gyn Concepts, Ltd. | 1987-05-06 |
| K852194 | MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET | Sharp Electronics Corp. | 1985-09-27 |
| K852801 | BIOCHRON FERTILITY INDICATOR | Fertil-A-Chron, Inc. | 1985-09-19 |
Legacy Summary#
summary
FDA Review#
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